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CONDITIONS
AND DISEASES PREVENTED AND HELPED BY A LOW-CARB, HIGH-FAT DIET

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Why Breast Feeding is Best, and a Lot Safer that soy based formula

Below are news stories about the mistakes that can always happen when we do things that aren't natural. Formula milks for babies will never be as good or as safe as the real thing — human breast milk.

While these sorts of accidents are rare, the makeup of formula feeds will never have the full range of, not only nutrients, but the elements that confer disease resistance to children. These only come from the real thing.

There are very few women who cannot breast feed if properly taught. Breast feeding should be the norm; today, it tends to be the exception. But you are going to put a great deal of time effort, and expense into raising a child. It can be a happy time; all too often it is a trying time. Either way, the health of your offspring – the reward for all the work you put in is a happy, healthy and intelligent child. But for that, it is essential do the job properly and feed your baby the right food. And, for the first several months, that means human breast milk.

Babies fed defective formula are still being treated for neurological damage

Jerusalem Judy Siegel-Itzkovich

A year after the deaths from encephalopathy of two Israeli infants who were exclusively fed a soya formula made in Germany that lacked vitamin B1 (thiamin) (BMJ 2003;327:1128) nine children are still being treated for serious neurological damage.

Although they regularly undergo blood tests and other procedures several of them feel no pain and never cry. A recent Israeli cable TV documentary on the most seriously disabled children showed them staring into space and barely able to move. While some babies being treated are improving, others seem to be irreversibly damaged.

A total of 35 infants identified after the two deaths as having been fed for months solely on the vitamin deficient formula were given urgent thiamin injections. Of these, 10 have no symptoms and are being watched closely for any long term neurological effects. Because beriberi (thiamin deficiency) is almost unknown in developed countries, it took some time for doctors to identify the cause of the deaths and neurological complications.

Humana Milchunion, the manufacturer in Herford, North Rhine-Westphalia, that supplied the non-dairy baby formula to Israel, admitted its negligence, dismissed four employees, and agreed in principle on financial compensation, which is expected to total between $15m (Â£8m; 10m Euros) and $25m when finalised. Humana claimed that it stopped adding synthetic thiamin because it believed that soya beans had enough natural thiamin.

A senior Israeli police investigation team recently recommended the indictment of senior employees at Remedia, the formula's local importer and distributor. Israeli police are continuing to question the health ministry officials responsible for supervising the safety of locally manufactured and imported food, while German police are continuing their investigation.
The health ministry said that it was impossible to prevent a recurrence of such an incident, as there will never be enough staff to test all food manufactured or distributed in Israel. Companies that meet strict criteria and are approved under good manufacturing practice regulations have been trusted to supervise and test themselves. "But we are doing our best to make a recurrence very unlikely," the ministry said.

Baby foods are now regarded as "sensitive products" that are sampled and tested regularly like drugs. The ministry seeks legislation that would raise fines considerably against violators whose products do not meet nutritional claims on the label. "The fines are very out of date and do not deter violations," the ministry said.

Publicity about the harm caused to the babies has increased the number of breastfeeding mothers in Israel. The ministry has also discouraged the use of soya based formula, saying that powder based on cow's milk is preferable. Even though allergies to cow's milk affect only 2% to 3% of newborn babies, five or six times as many babies were given the non-dairy formula because of misconceptions and misinformation. This was especially true among ultra-Orthodox Jewish families who opted for soya formula to avoid mixing milk and meat.

BMJ 2004;329:310 (7 August), doi:10.1136/bmj.329.7461.310-d

News extra

Baby milk manufacturers agree out of court settlement

Jerusalem Judy Siegel-Itzkovich

The German company Humana Milchunion, which makes baby food, has agreed to an out of court settlement with parents of two Israeli infants who died from, and dozens more who were harmed by, a soya baby formula that it sent to Israel without the vital vitamin B-1 (thiamine) that was marked on the label.

The incident nine months ago shocked Israelis and especially the parents, who said they felt they had unknowingly poisoned their babies by feeding them the kosher formula, which was specially prepared for Israel (BMJ 2003;327:1128 (News Extra, doi: 10.1136/bmj.327.7424.1128-i)).

Vitamin B-1 is vital in the development of newborns' central nervous systems; if they are not breast fed and their nutrition is solely dependent on a vitamin deficient formula, they could die or have long term neurological deficits.

Because of an agreement with the Israeli importer, Remedia, the company, in the German town of Herford, did not disclose the exact financial commitment it made, but television reports said that Humana had offered between $16m (Â£8.8m; ?13.3m) and $22m to be divided among the families. These sums would make it among Israel's largest?and speediest?settlement for a manufacturer's negligence.

"Humana stands by its responsibility as a company in connection with the tragic events in Israel and will act accordingly in the future as well," Humana said. "The management and the employees of Humana feel deep and sincere sympathy with the affected families."

The German company dismissed four employees whom it blamed for the error. In addition, German prosecutors are investigating one of the workers. Israel's police, who questioned employees of Remedia (partly owned by the giant US food company H J Heinz) and others for alleged criminal negligence, is due to make recommendations to the judicial system soon.

It took time for hospital doctors and health ministry epidemiologists to link the deaths of the two infants who died last year to the absence of thiamine. By then, a few dozen more cases of harm had been reported. Fifteen children continue to have serious problems, including a 1 year old girl who is growing but has convulsions and respiratory problems and cannot move her limbs or communicate with her family.

Parents said the money offered by Humana would help them to provide treatments and buy special equipment for their babies, whose long term health and future is unknown.
Since the story broke, Israel's health ministry has changed the classification of baby foods; they are now classed as pharmaceuticals, and their contents must therefore be strictly tested before marketing.

BMJ 2003;327:1128 (15 November), doi:10.1136/bmj.327.7424.1128-i

News extra

Police in Israel launch investigation into deaths of babies given formula milk

Jerusalem Judy Siegel-Itzkovich

The Israel police have launched a criminal investigation into the deaths from beriberi of two infants and the hospitalisation of 13 more who since August were fed a German made, non-dairy, baby formula made for sale only in Israel.

The special line of soya based formula?found by Israel's health ministry to "totally lack" the vital vitamin B-1 (thiamine)?was produced by the Humana company in Herford, Germany, one of the largest baby food manufacturers in Europe with an annual turnover of 3bn Euros (Â£2.1bn; $1.2bn).

After two days of insistent denials of any error or wrongdoing, Humana finally took "technical and scientific responsibility" for the failure.

The company's chairman, Albert Grossa Fray, said at a press conference on Tuesday that the company believed the amount of thiamine found naturally in the soya beans was sufficient and that no synthetic vitamin needed to be added.

But Humana claimed that Remedia, the Israeli importer of the baby formula, had asked for this change. Senior Remedia officials denied this, saying they had been "misled" by the German company and had only asked for a "minor change of the fat components" of the non-dairy formula, but were unaware that the manufacturer had made a major change and eliminated the B-1 vitamin enrichment.

Fray said the formula sent to Israel contained "10 times less" the amount of thiamine as stated on the formula's container; the amount of vitamin B-1 in the formula amounted to 29 to 37 micrograms per 100 g, while the label said it had only 385 micrograms per 100 g.

The company called the lack of the optimum level of vitamin a "terrible mistake" but emphasised that this one-time error did not affect any of the company's other products.

The Israeli health ministry's director general, Dr Boaz Lev, charged that not only Humana was responsible, but also Remedia (51% of which is owned by the US based company H J Heinz) for having not informed the ministry of changes in the composition of the formula.

"Even a minor change required that we be informed and that Remedia apply for a new licence for the formula, as it is considered a new product."

But Remedia said that it had "no clue" that Humana removed the vitamin, and claimed that the change in fats?apparently to expand the market to older babies?was only a minor one that didn't require reapplication.

Dr Lev said that the lack of thiamine in the packaged formula constituted "fraud" as this vital component was listed on the label.

The problem started when doctors at Schneider Medical Centre for Israel in Petah Tikva (the largest children's hospital in the Middle East) noted that three infants had been admitted with encephalopathy within a week.

Ministry epidemiologists examined more than a dozen recent infant encephalopathy cases and found a common denominator: All had been exclusively or mainly fed the non-dairy Remedia formula.
Although beriberi is unknown in the Western world, a doctor at a Tel Aviv hospital identified it in a 9 month old baby admitted with encephalopathy and informed the ministry of the connection. Nine of the 10 babies still hospitalised have substantially improved after getting vitamin B-1 injections.

But Professor Tommy Scheinfeld, head of Schneider's intensive care unit, said there are no data in the medical literature on the long term effects of severe thiamine deficiency in Western babies; infants in the developing world develop beriberi and die quickly due to malnutrition and poor environmental conditions.

Manager at baby food company is under investigation for manslaughter

German state prosecutors have launched an investigation into a manager at the baby food manufacturer Humana after the deaths of two infants in Israel (BMJ 15 November, News extra).

Harald KrahmÃ¼ller, spokesman for the state prosecution office in Bielefeld, North Rhine-Westphalia, said that the head of Humana's product development department was expected to be charged with manslaughter and causing grievous bodily harm after she failed to ensure that a non-dairy baby formula made for sale only in Israel was submitted to independent quality control measures.
The police are also questioning other staff at the Herford based company – one of the largest baby food manufacturers in Europe – after a series of errors that allowed baby food without vitamin B-1 to go on sale in Israel.

The investigation comes as it emerged that doctors in Germany had lodged a complaint about Humana's "totally misleading advertising" in July.

The German Association for Children's Healthcare and Youth Medicine had written to the state's regulatory agency, urging it to use its powers to scrutinise the standards at the baby food manufacturer.

A paediatrician from the association, Berthold Koletzko, said that the lives of the infants in Israel could have been saved if the authorities had implemented a new EU directive ordering all new recipes for baby food to be submitted to quality control measures at independent laboratories before being sold.

After the public outcry, authorities in North Rhine-Westphalia have promised a massive reorganisation of the 18 agencies currently responsible for scrutinising food standards.

In another blow to Humana, Russia last Thursday announced a ban of all of Humana's products, as well as those of Remedia, Humana's partner in Israel. The Russian government's chief epidemiologist, Gennadi Onischtschenko, went on television to say that Humana and Remedia's products would be submitted to independent tests to determine whether they contained enough of the vital vitamin B-1.

Last updated 14 November 2004

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